Board of Governors Meeting via Teleconference/Webinar August 18, 2015 12:00-1:30 p.m. ET
Welcome and Introductions Grayson Norquist, MD, MSPH Chair, Board of Governors Joe Selby, MD, MPH Executive Director
Agenda Time Agenda Item 12:00- Call to Order, Roll Call, and Welcome 12:05 Consider for Approval: Minutes of July 21, 2015 Board Meeting 12:05- Consider for Approval: 12:20 Slate of PCORnet Obesity Demonstration Awards 12:20- Consider for Approval: 12:35 Slate of Winter 2015 Large Pragmatic Studies Awards 12:35- Consider for Approval: 1:20 • Treatment-Resistant Depression • Long-term Opioid Treatment for Chronic Pain New Oral Anti-coagulants • 1:20- 1:25 Annual Meeting Update 1:25 Wrap Up and Adjournment
Board Vote • Approve the July 21, 2015 Board Meeting Call for a Motion to: Minutes • Second the Motion Call for the Motion • If further discussion, may propose an to Be Seconded: Amendment to the Motion or an Alternative Motion • Vote to Approve the Final Motion Voice Vote: • Ask for votes in favor, opposed, and abstentions
PCORnet Obesity Observational Research Initiative Awards Joe Selby, MD, MPH Executive Director Rachael Fleurence, PhD Program Director, CER Methods and Infrastructure
Project Development • Topic generation and prioritization was coordinated through the PCORnet Obesity Task Force and included input from the PCORnet community, patients and stakeholders in the target population, outside experts, obesity experts, and observational researchers Two topics were prioritized by the Obesity Task Force and sent to the • Advisory Panel on Disparities for comment and approval: • Comparative effectiveness of bariatric surgery interventions • Comparative effectiveness of alternative antibiotics on weight outcomes in pediatric populations • PFA development was approved by the Science Oversight Committee on January 6, 2015 • Both topics were approved by the Board for PFA development on January 27, 2015
Goals of the PFA • There were three main goals of the limited PFA: Support research on important unanswered clinical questions faced 1. by patients and their clinicians using PCORnet’s Distributed Research Network and associated processes and programs Test and evaluate the capacity of PCORnet’s data infrastructure and 2. report on the readiness of PCORnet’s data infrastructure for observational research Provide an opportunity for PCORnet investigators, patients and 3. stakeholders to organize and collaborate in a multi-site study and develop efficient, collaborative processes for doing so
Review Criteria • The following criteria were used to evaluate the submitted applications: Technical merit 1. Patient-centeredness 2. Patient and stakeholder engagement 3. Infrastructure testing and evaluation plan 4.
Application Review • Application underwent rigorous technical and merit review • Application was reviewed by a panel of external merit reviewers including patients, researchers, and other stakeholders • Following PCORI process, additional information was requested from applicants based on concerns and questions raised in merit review • An Advisory Panel on Clinical Trials subcommittee comprised of merit review panelists, Methodology Committee members, and other experts has been formed to advise PCORI in protocol refinement and monitoring the trial on an as needed basis
Slate Summary Project Title Total Budget Bariatric Study $4,499,999 Short- and Long-term Effects of Antibiotics on Childhood Growth $4,499,142
Obesity Observational Research Initiative Bariatric Study • Study Aims: To what extent does weight loss and regain differ across three 1. bariatric surgical procedures: Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy at 1, 3, and 5 years? To what extent do these bariatric procedures differ on 2. improvements in diabetes risk at 1, 3, and 5 years? What is the frequency of major adverse events following these 3. three different bariatric surgical procedures at 1, 3, and 5 years?
Obesity Observational Research Initiative Short- and Long-term Effects of Antibiotics on Childhood Growth • Study Aims: 1. Compare the effects of different types, timing, and amount of antibiotic used in the first 2 years of life on body mass index (BMI) and risk of obesity at ages 5 and 10 years 2. Compare the effects of different types, timing, and amount of antibiotic used in the first 2 years of life on the rates and patterns of childhood growth during first 5 years of life 3. Explore how the effects of different types, timing, and amount of antibiotics on childhood BMI, obesity risk, and growth vary according to patient socio-demographic, clinical, and maternal characteristics
Slate Overview: 2 Obesity Observational Research Initiative New Projects Proposed Total Average Project PFA Announced Budget* Budget* Obesity Observational $9,000,000 $8,999,141 $4,499,570 Research Initiative *Total budget = direct + indirect costs All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.
Board Vote • Approve funding for the recommended slate of awards for the PCORnet Obesity Observational Call for a Motion to: Research Initiative PFA • Second the Motion Call for the Motion • If further discussion, may propose an Amendment to the Motion or an Alternative to Be Seconded: Motion • Vote to Approve the Final Motion Roll Call Vote: • Ask for votes in favor, opposed, and abstentions
Large Pragmatic Studies to Evaluate Patient-Centered Outcomes Winter 2015 Cycle Award Slate Christine Goertz, DC, PhD Chair, Winter 2015 Selection Committee Bryan Luce, PhD, MBA Chief Science Officer
Winter 2015 Pragmatic Studies Cycle Overview and Slate Recommendation
Winter 2015 Pragmatic Studies PFA • Goal of PFA: • Fund pragmatic clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for – Addressing prevention, diagnosis, treatment, or management of a disease or symptom – Improving health care system- level approaches to managing care – Eliminating health or healthcare disparities • Up to $10M in direct costs and up to 5 years duration • Funds available up to $90M total costs
Winter 2015 Pragmatic Studies Merit Review Criteria 1. Impact of the condition on the health of individuals and populations 2. Potential for the study to improve health care and outcomes 3. Technical merit 4. Patient-centeredness 5. Patient and stakeholder engagement
Slate Overview – Winter 2015 Pragmatic Studies Process Overview • 132 Letters of Intent (LOIs) submitted and reviewed • 32 LOIs invited to submit full application (24% of all LOIs) • 24 applications submitted (75% of invited) and reviewed at Merit Review • Convened post-Merit Review methodology consultation panel with the assistance of our Methodology Committee and Advisory Panel on Clinical Trials • We are proposing to fund 4 projects
Winter 2015 Pragmatic Studies Funding Slate 4 Recommended Projects* Project Title Comparing Outcomes of Drugs and Appendectomy (CODA) Integrated Versus Referral Care for Complex Psychiatric Disorders in Rural Federally Qualified Health Centers (FQHCs) (**1, 3) Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER): Balancing Safety and Effectiveness (**2) Integrating Behavioral Health and Primary Care (**1, 3) *All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract. ** 1: PCORI Priority; 2: IOM CER 100; 3: AHRQ Future Research Needs—priority areas are not mutually exclusive
Project #1 Comparing Outcomes of Drugs and Appendectomy (CODA) • Research Question • Is the use of an antibiotics-first approach "as good as" an appendectomy for treating uncomplicated appendicitis? • Study Design/Sample Size/Population • RCT with a parallel observational cohort; 1,552 adults presenting with a diagnosis of uncomplicated appendicitis (CT, ultrasound, or MRI confirmed) at 10 practice sites in a state’s CER Translation Network • Outcomes • Primary: Rates of subsequent appendectomy in the “antibiotics first” arm, and the patient’s experience with appendicitis and its treatment using the European Quality of Life-5 Dimensions instrument at 90 days • Secondary: Gastrointestinal quality of life index, PROMIS, Global Health Short Form, Decision Regret Scale; signs, symptoms, and safety events related to appendicitis • Total Budget: $12,911,011
Project #1 (cont.) Comparing Outcomes of Drugs and Appendectomy (CODA) • Engagement • Patient advisory network, partnerships with 2 national clinical specialty groups, engaged leadership of major insurance companies (commercial insurers as well as Medicaid and Medicare) • Potential Impact • The project will provide accurate estimates of the comparative effectiveness of antibiotic therapy for acute appendicitis. It also will provide new evidence about recurrence of symptoms in patients who do and do not undergo appendectomy. This information will help to guide decision making by patients and their providers.
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